The Effect of Frailty on Blood Biology Indicators, Quality of Life and Survival of Patients With Radical Prostatectomy

Not yet recruiting

• Conditions: Prostatic Neoplasms; Frailty; Blood Biological Indicators; Quality of Life; Survival
• Interventions: Other: frailty

• Registration Number: NCT05941104
• Lead Sponsor: Anhui Provincial Hospital

Brief Summary

The goal of this observational study is to evaluate the effect of frailty on blood biology indicators, quality of life and survival of patients with radical prostatectomy.

The main questions it aims to answer are:

1. Evaluate the impact of frailty on the blood biological indicators, quality of life and survival of patients with radical prostatectomy, specifically.

2. Describe the longitudinal changes in the quality of life of patients with radical prostatectomy.

Participants will be divided into frail group or non-frail group based on frailty assessment. Researchers will compare the two groups to see the impact of frailty on the blood biological indicators, quality of life and survival.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-16
• Study First Submitted QC: 2023-07-09
• Last Update Submitted: 2023-07-09
• Study First Posted: 2023-07-12
• Last Update Posted: 2023-07-12
• Study Start: 2023-07-15
• Primary Completion: 2025-07-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

1. Diagnosed with prostate cancer (be diagnosed by relevant imaging examinations or pathology);
2. Radical prostatectomy is planned;
3. Voluntarily sign the informed consent form.

Exclusion Criteria

1. Diagnosed with other malignant tumors at the same time;
2. Patients with acute infection.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Frail group	frailty	-

Primary Outcome Measures

Name	Time	Method
Change of Quality of Life from baseline(Quality of Life is a generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral, social environment as well as health and disease.)	baseline(date of hospitalization); 1 month after operation; 3 months after operation; 6 months after operation; 1 year after operation; 2 years after operation.	Quality of life will be measured by the Extended Prostate Cancer Composite Index Scale (EPIC-26). EPIC-26 is used to assess the functional status of patients with prostate cancer in various domains over the past 4 weeks. Be si de s, EPIC-26 is used to describe the extent of its affects in life of patients with prostate cancer. EPIC-26 contains 26 items in five areas, including urinary incontinence, urinary tract irritation, defecation function, sexual function, and endocrine disorders. Cronbach α coefficient of the scale was 0.854. The overall score is 100 points, and the lower score means better quality of life.

Secondary Outcome Measures

Name	Time	Method
Blood Biology Indicators(including IL-2, IL-6, IL-8,TNF-α, PSA and et al)	baseline(date of hospitalization); 1 month after operation; 3 months after operation; 6 months after operation; 1 year after operation; 2 years after operation.